Controlled Substances Security Manual
Security Requirements for Non-Practitioner
Non-practitioners include manufacturers, packagers, labelers, distributors, importers, exporters, narcotic treatment programs, and compounders for narcotic treatment programs.
Small quantities of CI&II raw materials, bulk materials awaiting further processing, and finishing products must be stored in an Underwriters Lab (UL) listed burglary-resistant safe with a Group 1-R lock, or a General Services Administration (GSA) Class V rated security container, or the equivalent, which affords the following security protection:
- 30 man minutes against surreptitious entry,
- 10 man minutes against forced entry,
- 20 man hours against lock manipulation,
- 20 man hours against radiological attack.
This safe or security container must be bolted, strapped, or otherwise securely fastened to the floor or wall in such a way that it cannot be readily removed if it weighs less than 750 pounds. Depending upon the quantities and types of controlled substances stored, this safe or security container must be equipped with an alarm system which upon attempted unauthorized entry transmits a signal directly to a central protection company, a local or state police agency which has a legal obligation to respond, a 24-hour proprietary central station operated by the registrant, or such other protection as DEA may approve.
Large quantities of such controlled substances which do not permit storage in a safe or security container may be stored in a vault meeting the following specifications or equivalent, if constructed after September 1, 1971:
- The walls, floor and ceiling are constructed of at least eight inches of reinforced concrete or other substantial masonry reinforced vertically and horizontally with #4 (half inch) steel rods tied six inches on center, or UL listed modular vault panels.
- The door and frame unit are UL listed burglary-resistant, GSA Class V rated or equivalent, i.e., multiple position Group 1-R combination lock, relocking device, special metal alloy that resists carbide drilling, and in general affords the overall security protection set forth above for safes and security containers.
- If operations require the vault/container to remain open to frequent access, the door is required to be equipped with a day gate which is self-closing and self-locking. If the operation requires only that the vault be opened infrequently, such as to remove raw material in the morning and return it at night, and is always relocked immediately after use, a day gate is not required.
- The walls or perimeter are equipped with an alarm system which upon attempted unauthorized entry must transmit an alarm directly to a central protection company, local or state police agency which has a legal obligation to respond, a 24-hour proprietary central station operated by the registrant, or such other protection as DEA may approve. If necessary due to local condition or other problems, holdup buttons may be required to be placed at strategic points of entry or exit from the perimeter.
- The door is equipped with a contact switch(es) and there is complete electrical lacing of the walls, floors and ceiling, sensitive ultrasonic or infrared sensors within, a sensitive sound accumulator system, or other such devices or equipment designed to detect unauthorized entry as may be approved by the Drug Enforcement Administration (DEA).
Vaults constructed before or under construction on September 1, 1971 and approved by the Bureau of Narcotics and Dangerous Drugs or its predecessor agencies may be of substantial construction with a steel door, combination or key lock, and alarm system.
Note: DEA evaluates a registrant security system on an element-by-element and on and overall basis, measuring the system against the potential theft or diversion problem the registrant might encounter at the registered location. Thus, DEA may approve a security system although some of the specific standards are not met, e.g., a registrant who provides 24-hour guard surveillance may not need the full alarm protection as set forth in the regulations. A registrant who handles large quantities of in-process liquids running through a pipe system may not need to vaults this form of controlled substances because of the difficulties in containing or diverting the liquids and their possible non-restrictability. The minimum standards and general security requirements set forth above and below are used by DEA as a basis for making decisions on the specific security needs of each registrant.
Small quantities of C III-V controlled substances may be stored in a UL listed burglary-resistant safe or a GSA Class V rated security container or equivalent which complies with the requirements for storing C I& II substances. Large quantities of such controlled substances which do not permit storage in a safe or security container may be stored in:
- A building or area within a building having perimeter security which limits access during working hours, provides adequate security after working hours, and has the following security controls:
- An electronic alarm system as described above for C I&II controlled substances;
- Substantially constructed self-closing and self- locking doors employing either multiple-position combination or key lock type locking mechanisms (note: in lieu of self locking/closing doors, a door which is kept closed and locked at all times when not in use, and when in use is kept under direct observation of a responsible employee of the registrant is permitted); and
- Requisite key control, combination limitations, and change procedures.
- A cage within a building on the premises meeting the following specifications:
- Walls constructed of not less than ten gauge steel fabric mounted on steel posts which are:
- At least one inch in diameter;
- Set in concrete or installed with lag bolts which are pinned or brazed; and
- Placed no more than ten feet apart with horizontal one and one half-inch reinforcement every 60 inches.
- Mesh construction with openings not more than two and one half inches across the square;
- A ceiling constructed of the same material or walls extending to and firmly attached to the structural ceiling;
- A door constructed of the same gauge steel fabric on a metal door frame in a metal door flange; and
- An alarm system protecting the perimeter and interior as described above.
- Walls constructed of not less than ten gauge steel fabric mounted on steel posts which are:
- An enclosure of masonry or other such materials or secure storage area which has been approved by DEA.
Schedule III-V controlled substances may be stored with CI&II substances under the security measures required for those substances. CIII-V substances may be stored in the vault provided access to the area is not substantially increased and that permission for such storage is obtained in advance from the appropriate DEA Field Office.
On occasion it may be necessary for non-practitioner registrants to handle several classes of controlled substances separately. Some examples of these special circumstances are damaged goods, returned goods, goods in processing, etc. In these circumstances, controlled substances may be stored apart from the main stock of controlled substances, provided that each storage area complies with the security requirement set forth in the previously described minimum standards.
In order to minimize the possibility of diversion, the registrant must limit access to the storage areas for controlled substances to a minimum number of authorized employees. Although not specifically required, it may be necessary to institute some type of security pass system if the size, type, or other characteristics the firm dictate the need. Where it is necessary for employee or non-employee maintenance personnel, business guests, or other visitors to have access to or to pass through a controlled substances storage area, the registrant needs to provide authorization to those individuals. The authorization should be in writing, and the specially authorized individuals should be held under adequate observation during the time they are in the storage area.
Manufacturing activities (include processing, packaging, and labelling) involving controlled substances listed in any schedule, and all compounders, must implement the following security controls:
- All in-process substances must be returned to the controlled substances storage area at the termination of the process. If the process is not completed at the end to the work day, the processing area or tanks, vessels, bins, or bulk containers holding controlled substances must be securely locked inside an area or building which affords adequate security.
- Manufacturing activities with controlled substances must be conducted in an area(s) with limited access and must be kept under surveillance by and employee(s) designated in writing by management to be responsible for the area. The designated employee(s) must be able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without the designated employee's knowledge. Access may be limited by the use of physical dividers such as walls or partitions, by traffic control lines, or restricted space designations.
- During controlled substances production, the manufacturing areas should be accessible only to those employees necessary for efficient operation. If it becomes necessary for employee or non-employee maintenance personnel, business guests, or visitors to be present or to pass through manufacturing areas during production, it is in the best interest of the registrant to have an employee designated in writing as being responsible for providing adequate surveillance of the area.
Registrants who store controlled substances in public warehouses are responsible for selecting a facility that will provide adequate security to guard against losses and thefts. Whenever possible, the registrant should select a storage warehouses or terminal which meets the physical security requirement and controls set forth above and below, with the knowledge that it is the registrant, not the warehouseman, who is responsible for the security of the controlled substances. Other aspects of warehouse or terminal security which the registrant might consider are:
- Adequacy of fencing, lighting, electronic security, checkpoints, and other perimeter controls;
- Type of order tracking or tracing system in use, if any;
- Personnel screening, hiring, and control programs;
- Hours of operation;
- Use of contract or proprietary guards;
- Procedures and systems in use to control inbound and outbound tractors, trailers, containers, etc.;
- Yard control of drivers, tractors, trailers, containers, etc.
Registrants are also responsible for selecting common or contract carriers that will provide adequate security against in-transit losses or thefts. If the registrant has substantial quantities of controlled substances lost or stolen in transit when using a particular common or contract carrier, steps should be taken to obtain another secure carrier or means of transport. When evaluating common or contract carriers, in addition to evaluating warehouses or terminal security, the registrant might consider the following:
- Physical security of the vehicles, e.g.:
- Adequate vehicle and trailer locks subject to proper key control, and locking of vehicles at all times when unattended;
- Vehicular alarm systems in use at all times when vehicles and trailers are unattended;
- Fuel lock alarm devices;
- Page alert alarm system carried by drivers when away from vehicles and trailer to alert them to unauthorized opening of doors, hood, etc.
- Route variations to avoid patterns.
- Vehicles equipped with CB's or other radios to communicate with local law enforcement agencies or the company warehouse or terminal in the event of an emergency or other duress condition.
- Special code numbers or symbols painted on or otherwise affixed to the roof.
- Driver screening, hiring and control programs.
- Overall priority and security afforded controlled substances shipments.
- Use of subcontracted carriers.
These security aspects and procedures are also applicable when delivering and picking up controlled substances using company-owned or leased vehicles operated by company employees. Although not required, precautions such as securely wrapping and sealing packages containing controlled substances and using unmarked or coded boxes or shipping containers are strongly recommended for guarding against in-transit losses.
Registrants must notify the appropriate DEA field office of theft or significant loss of any controlled substance. Furthermore, the supplier is responsible for reporting in-transit losses of controlled substances by a common or contract carrier. The registrant must then promptly complete and submit the DEA Form 106 regarding such losses or thefts. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties identified and action taken against them.